BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 3240954 · Received July 17, 2013

    Report

    Report Number
    2916710-2013-00014
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AT THIS TIME. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE RT SELECTED AUTO TO MOVE THE GANTRY TO THE PLANNED POSITION OF 5 DEGREES. WHEN THIS WAS BEING EXECUTED THE COUCH WAS ALSO SEEN TO HAVE MOVED SLIGHTLY (2MM). THEY CHECKED IN RT CHART AND WERE NOT MISTAKEN, SO TO REMEDY THIS, THE COUCH WAS MOVED BACK TO SAME LATITUDE AND LONGITUDE AS THE BREAST FIELDS AND TREATMENT CONTINUED. THE TOLERANCE TABLES HAVE BEEN CHECKED AND THEY ARE SET TO MANUAL SO NO COUCH MOTION SHOULD HAVE HAPPENED WITH THIS AUTO MOVE FROM THE PENDANT. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332401 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1